The following data is part of a premarket notification filed by Micro-aire Surgical Instruments, Inc. with the FDA for Micro-aire Pulse Lavage.
Device ID | K874504 |
510k Number | K874504 |
Device Name: | MICRO-AIRE PULSE LAVAGE |
Classification | Lavage, Jet |
Applicant | MICRO-AIRE SURGICAL INSTRUMENTS, INC. 505 FOURTH ST. San Fernando, CA 91340 |
Contact | Siddharth Desai |
Correspondent | Siddharth Desai MICRO-AIRE SURGICAL INSTRUMENTS, INC. 505 FOURTH ST. San Fernando, CA 91340 |
Product Code | FQH |
CFR Regulation Number | 880.5475 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-11-02 |
Decision Date | 1987-12-29 |